Information for Research Participants

The University of North Dakota recognizes the importance of your decision to participate in a research study. Your participation in the study is voluntary, and you may choose not to participate or you may discontinue your participation at any time. Your decision whether or not to participate will not affect your current or future relations with the University of North Dakota.

Questions?

• The investigator conducting the study provides contact information for specific questions about the study procedures. You may contact the investigator with questions at anytime during or after the study.
• If you can’t reach the investigator or wish to discuss the study with someone other than the investigator, you may contact the Institutional Review Board at 701.777.4279 or via email to: UND.irb@UND.edu.
• If you have questions regarding your rights as a research subject, or if you’d like to discuss problems or concerns; obtain information; or offer input with an informed individual who is unaffiliated with the research project, you may contact the Institutional Review Board at 701.777.4279 or UND.irb@UND.edu. All calls and emails will remain confidential, and if you prefer, anonymous.

Information About Becoming a Research Participant

• About Research Participation: A public outreach website created by the Office of Human Research Protections, U.S. Department of Health and Human Services
• Becoming a Research Volunteer: It’s Your Decision: Brochure created by the Office of Human Research Protections, U.S. Department of Health and Human Services
• Clinical Research Trials and You: National Institutes of Health, U.S. Department of Health and Human Services
• Clinical Trials: What You Need to Know: American Cancer Society

Community-Based Participatory Research Links

• What is Community-Based Participatory Research?
• Ethical Considerations for Community Engagement in Research
• Ethics and Research in the Community
• Community-Campus Partnerships for Health
• Developing and Sustaining CBPR Partnerships: A Skill Building Curriculum
• Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

Ethics Principles for Research

• The Nuremburg Code: Office of Research Integrity, U.S. Department of Health and Human Services
• Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects: The World Medical Association
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research: Office of Human Research Protections, U.S. Department of Health and Human Services

Federal Regulations Governing Human Subjects Research

• Department of Health and Human Services (DHHS): 45 CFR 46 ("The Common Rule" - Human Subject Protections)
• Food and Drug Administration (FDA)
  • 21 CFR 50 (Protection of Human Subjects)
  • 21 CFR 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drugs)
  • 21 CFR 812 (Investigational Device Exemptions)
• Comparison of FDA and HHS Human Subject Protection Regulations (by FDA)